BMS’s Oral Kinase Inhibitor Inrebic Recommended by NICE for Myelofibrosis Treatment in NHS

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The UK National Institute for Health and Care Excellence (NICE) has recently issued a Final Appraisal Decision (FAD), recommending the use of Bristol-Myers Squibb's oral kinase inhibitor Inrebic (fedratinib) within the National Health Service (NHS) for the treatment of myelofibrosis, a rare blood cancer that affects the bone marrow and disrupts the production of blood cells in the body. Eligible adult patients with primary or secondary myelofibrosis will now be able to access Inrebic treatment through the NHS.

Symptoms of myelofibrosis often weaken patients, including fatigue, itching, weight loss, night sweats, fever, bone pain, and splenomegaly. The median survival period for patients with myelofibrosis is about 6 years, although the disease is divided into different risk categories. In the high-risk stage of this disease, the prognosis is worse, with about 60% of patients diagnosed in this category. About 10-20% of patients with myelofibrosis can progress to acute myeloid leukemia (AML), an aggressive blood cancer.

Inrebic is recommended within the Cancer Drugs Fund (CDF) for adult patients with primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis who have previously been treated with ruxolitinib, to treat disease-related splenomegaly or symptoms.

Professor Claire N. Harrison, Clinical Director of London NHS Foundation Trust and Myeloproliferative Neoplasms expert, noted that myelofibrosis is a serious and often debilitating bone marrow condition, with associated symptoms significantly impacting patients' quality of life. Before the NICE decision, NHS clinicians had few alternatives when treating patients unresponsive to current standard-of-care therapies, making Inrebic a highly welcomed new treatment option to help manage care for these patients.

The active pharmaceutical ingredient in Inrebic is fedratinib, an oral kinase inhibitor with activity against wild-type and mutationally activated Janus-associated kinase 2 (JAK2) and FMS-like tyrosine kinase 3 (FLT3). Fedratinib is a JAK2-selective inhibitor, demonstrating a higher inhibitory effect on JAK2 compared to family members JAK1, JAK3, and TYK2. Aberrant activation of JAK2 is associated with myeloproliferative neoplasms (MPN), including myelofibrosis and polycythemia vera.

Inrebic, obtained by Bristol-Myers Squibb through the $74 billion acquisition of Celgene, was approved in the United States in August 2019 and in the European Union in February 2021. It is the first new drug for myelofibrosis approved in the US and EU in nearly a decade. Inrebic is suitable for patients who have not previously received treatment and those who have been treated with ruxolitinib. Ruxolitinib, a JAK1/JAK2 inhibitor developed by Novartis and Incyte, was approved for marketing in 2011 and is the first drug to treat myelofibrosis.

Reference Source: NICE Recommends Inrebic for Rare Blood Cancer